ID

14119

Description

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Keywords

Versions (1)
  1. 3/30/16 3/30/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 30, 2016

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA (Uns)

English

VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA (Uns)

1 forms  
PK Sampling TAC/CsA (Uns)
Description

PK Sampling TAC/CsA (Uns)

Type of most recent immunosuppressant intake prior to this visit
Description

Type of most recent immunosuppressant intake prior to this visit

Data type

integer

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0332152
actual date and time of most recent intake of immunosuppressant prior to this visit
Description

actual date and time of most recent intake of immunosuppressant prior to this visit

Data type

datetime

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C0011008
actual date and time of sampling
Description

sampling date and time

Data type

integer

Alias
UMLS CUI [1,1]
C0870078
UMLS CUI [1,2]
C0011008
remarks if any
Description

remarks

Data type

text

Alias
UMLS CUI [1]
C0947611
immunosuppressant concentration
Description

immunosuppressant concentration

Data type

text

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1446561
immunosuppressant concentration unit
Description

immunosuppressant concentration unit

Data type

integer

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1446561
UMLS CUI [1,3]
C1519795
local laboratory name
Description

local laboratory name

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1301943
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Similar models

VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA (Uns)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PK Sampling TAC/CsA (Uns)
Item
Type of most recent immunosuppressant intake prior to this visit
integer
C0021081 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Type of most recent immunosuppressant intake prior to this visit
Code List
Type of most recent immunosuppressant intake prior to this visit
CL Item
Tacrolimus (1)
CL Item
Cyclosporin A (2)
actual date and time of most recent intake of immunosuppressant prior to this visit
Item
actual date and time of most recent intake of immunosuppressant prior to this visit
datetime
C0021081 (UMLS CUI [1])
C0545082 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
actual date and time of sampling
integer
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
sampling date and time
Code List
actual date and time of sampling
CL Item
not done (1)
CL Item
same date as visit date (2)
CL Item
other date please specify: (3)
remarks
Item
remarks if any
text
C0947611 (UMLS CUI [1])
immunosuppressant concentration
Item
immunosuppressant concentration
text
C0021081 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
Item
immunosuppressant concentration unit
integer
C0021081 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
immunosuppressant concentration unit
Code List
immunosuppressant concentration unit
CL Item
mcg/ml (1)
CL Item
ng/ml (2)
CL Item
pg/ml (3)
local laboratory name
Item
local laboratory name
text
C0022877 (UMLS CUI [1,1])
C1301943 (UMLS CUI [1,2])
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